The Effect of an Oxytocin Decision Support Checklist on Oxytocin Use and Maternal and Neonatal Outcomes: A Retrospective Cohort Study.

OBJECTIVE: To assess the association between use of an oxytocin decision support checklist with oxytocin usage and clinical outcomes. STUDY DESIGN: We conducted a retrospective cohort study of patients with singleton gestations at 370/7 weeks or greater who received oxytocin during labor from October 2012 to February 2017 at an integrated community health care system during three exposure periods: (1) pre-checklist; (2) after paper checklist implementation; and (3) after checklist integration into the electronic medical record (EMR). The checklist was a clinical decision support tool to standardize the dosing and management of oxytocin. Thus, our primary outcomes included oxytocin infusion rates and cumulative dose. Secondary outcomes included maternal and neonatal outcomes. We controlled for maternal risk factors with multivariable regression analysis and stratified by mode of delivery. RESULTS: A total of 34,269 deliveries were included. Unadjusted analyses showed that compared with pre-checklist, deliveries during the paper and EMR-integrated periods had a lower cumulative dose (4,670 ± 6,174 vs. 4,318 ± 5,719 and 4,286 ± 5,579 mU, p < 0.001 for both), lower maximal infusion rate (9.9 ± 6.8 vs. 8.7 ± 5.8 and 8.4 ± 5.6 mU/min, p < 0.001 for both), and longer duration of oxytocin use (576 ± 442 vs. 609 ± 476 and 627 ± 488 minutes, p < 0.001 and p = 0.01, respectively). The unadjusted rates of cesarean, 5-minute Apgar <7, mechanical ventilation, and neonatal hospital length of stay were similar between periods. The adjusted mean difference in time from admission to delivery was longer during the EMR-integrated period compared with pre-checklist (3.0 [95% confidence interval: 2.7-3.3] hours, p < 0.001). CONCLUSION: Oxytocin checklist use was associated with decreased oxytocin use patterns at the expense of longer labor times. Findings were more pronounced with EMR integration. KEY POINTS: · An oxytocin decision support checklist is associated with reduced amounts of oxytocin used.. · However, checklists were associated with longer duration of oxytocin use and of labor.. · Results were more pronounced in the EMR-integrated checklist compared with paper checklist..

Mild Traumatic Brain Injuries and Risk for Affective and Behavioral Disorders.

OBJECTIVES: Recent studies document an association between mild traumatic brain injuries (mTBIs) in children and postinjury psychiatric disorders. However. these studies were subject to limitations in the design, lack of long-term follow-up, and poorly defined psychiatric outcomes. This study determines the incidence and relative risk of postinjury new affective and behavior disorders 4 years after mTBIs. METHODS: A cohort study of mTBI cases and matched comparisons within an integrated health care system. The mTBI group included patients ≤17 years of age, diagnosed with mTBI from 2000 to 2014 (N = 18 917). Comparisons included 2 unexposed patients (N = 37 834) per each mTBI-exposed patient, randomly selected and matched for age, sex, race/ethnicity, and date of medical visit (reference date to mTBI injury). Outcomes included a diagnosis of affective or behavioral disorders in the 4 years after mTBI or the reference date. RESULTS: Adjusted risks for affective disorders were significantly higher across the first 3 years after injury for the mTBI group, especially during the second year, with a 34% increase in risk. Adjusted risks for behavioral disorders were significant at years 2 and 4, with up to a 37% increase in risk. The age group with the highest risk for postinjury affective and behavioral disorders was 10- to 13-year-old patients. CONCLUSIONS: Sustaining an mTBI significantly increased the risks of having a new affective or behavioral disorder up to 4 years after injury. Initial and ongoing screening for affective and behavior disorders following an mTBI can identify persistent conditions that may pose barriers to recovery.

A comparative effectiveness study of carotid intervention for long-term stroke prevention in patients with severe asymptomatic stenosis from a large integrated health system.

OBJECTIVE: The results of current prospective trials comparing the effectiveness of carotid endarterectomy (CEA) vs standard medical therapy for long-term stroke prevention in patients with asymptomatic carotid stenosis (ACS) will not be available for several years. In this study, we compared the observed effectiveness of CEA and standard medical therapy vs standard medical therapy alone to prevent ipsilateral stroke in a contemporary cohort of patients with ACS. METHODS: This cohort study was conducted in a large integrated health system in adult subjects with 70% to 99% ACS (no neurologic symptom within 6 months) with no prior ipsilateral carotid artery intervention. Causal inference methods were used to emulate a conceptual randomized trial using data from January 1, 2008, through December 31, 2017, for comparing the event-free survival over 96 months between two treatment strategies: (1) CEA within 12 months from cohort entry vs (2) no CEA (standard medical therapy alone). To account for both baseline and time-dependent confounding, inverse probability weighting estimation was used to derive adjusted hazard ratios, and cumulative risk differences were assessed based on two logistic marginal structural models for counterfactual hazards. Propensity scores were data-adaptively estimated using super learning. The primary outcome was ipsilateral anterior ischemic stroke. RESULTS: The cohort included 3824 eligible patients with ACS (mean age: 73.7 years, 57.9% male, 12.3% active smokers), of whom 1467 underwent CEA in the first year, whereas 2297 never underwent CEA. The median follow-up was 68 months. A total of 1760 participants (46%) died, 445 (12%) were lost to follow-up, and 158 (4%) experienced ipsilateral stroke. The cumulative risk differences for each year of follow-up showed a protective effect of CEA starting in year 2 (risk difference = 1.1%, 95% confidence interval: 0.5%-1.6%) and persisting to year 8 (2.6%, 95% confidence interval: 0.3%-4.8%) compared with patients not receiving CEA. CONCLUSIONS: In this contemporary cohort study of patients with ACS using rigorous analytic methodology, CEA appears to have a small but statistically significant effect on stroke prevention out to 8 years. Further study is needed to appropriately select the subset of patients most likely to benefit from intervention.

Fetal heart rate patterns and the incidence of adverse events after oral misoprostol administration for cervical ripening among low-risk pregnancies.

OBJECTIVE: Though misoprostol is commonly used for inpatient cervical ripening, its use in outpatient settings has been limited by safety concerns. This study was conducted to assess the association between early fetal heart tracing (FHT) and maternal tocodynamometry patterns and the incidence of adverse fetal and pregnancy outcomes after the administration of oral misoprostol for cervical ripening. METHODS: We conducted a retrospective cohort study of 9908 low-risk patients at ≥37 weeks gestation who received oral misoprostol for cervical ripening prior to rupture of membranes between 01/01/2012 and 12/31/2017 at Kaiser Permanente Northern California hospitals as inpatients. We excluded patients who received a different agent for cervical ripening or had any need for additional inpatient monitoring, including hypertensive disorders of pregnancy, diabetes, or intrauterine growth restriction. Abnormal FHT, abnormal uterine activity, and adverse pregnancy or fetal-related events documented in the electronic health record in the four hours after administration of the first and second doses of misoprostol were assessed using descriptive statistics. RESULTS: We found that 0.9% of patients experienced tachysystole after the first dose of misoprostol (0.6% without decelerations; 0.3% with decelerations). The incidence of variable decelerations only and other FHT abnormalities (i.e. bradycardia, late or prolonged decelerations, or absent or minimal variability) in the first hour after misoprostol administration were 7.1% and 6.7% respectively, and diminished over time. The need for tocolytic use was 0.2% in the first hour and declined over time to 0.03% in the fourth hour after the first dose. Urgent cesarean delivery occurred in 0.1% of patients after receiving the first dose of misoprostol. Patients who did not experience variable, prolonged, or late decelerations in the first hour after the initial misoprostol dose were less likely to have such FHT abnormalities in the subsequent three hours compared to patients who had other FHT abnormalities (11.8% among patients with no FHT abnormalities vs. 43.7% among patients with other FHT abnormalities; p <.001). The overall trends in outcomes over time were similar after the second dose of misoprostol. CONCLUSION: The risk of short-term adverse outcomes associated with misoprostol is low among relatively low-risk patients. FHT abnormalities occurred in up to 32% of patients in the first four hours of monitoring post-misoprostol. Patients with no FHT abnormalities in the first hour after receiving misoprostol had a low risk of developing adverse outcomes and FHT abnormalities on continued monitoring, while patients with any type of deceleration in the first hour were at higher risk of adverse outcomes and FHT abnormalities. Our data may inform the development of protocols for cervical ripening that allow reduced monitoring for a subset of low-risk patients, however, more research is needed to validate findings and develop clinical protocols.

Urinary Tract Infections Among Gender Diverse People Assigned Female at Birth on Testosterone.

IMPORTANCE: The current literature lacks evidence to support the relationship between gender-affirming testosterone use and urinary tract infections (UTIs). OBJECTIVES: The aims of the study are to compare UTI rates among gender diverse people assigned female at birth on testosterone (GDT) to cisgender women (CW) and to identify factors associated with UTI. STUDY DESIGN: This is a retrospective cohort study of GDT and age-matched CW over a 5-year period. The primary outcome was based on the International Classification of Diseases, Ninth/Tenth Revisions, Clinical Modification, UTI diagnosis codes with a filled pharmacy order for antibiotics within 7 days of the diagnosis. RESULTS: The study included 2,401 GDT who were then age matched to 2,401 CW. The mean rates of UTI among GDT and CW were not significantly different at 0.09 and 0.10 UTIs per year, respectively. During the study period, 6.9% of GDT and 7.5% of CW had at least 1 UTI. Diabetes mellitus type 1 or 2 was significantly associated with UTI frequency among CW (P = 0.04) but not GDT (P = 0.96). CONCLUSIONS: The rate of UTIs among our young cohort of GDT and CW was similarly low. Diabetes mellitus type 1 or 2 was significantly associated with UTIs among CW but not GDT. These findings suggest that testosterone-induced vaginal atrophy may not be associated with a higher a UTI risk. A deeper understanding of the pathogenesis of UTI in people assigned female at birth and more data on the relationship between testosterone and UTIs are needed before recommending vaginal estrogen to all GDT with recurrent UTI.

Patient and Visit Characteristics Associated With Physical Restraint Use in the Emergency Department.

Objective Physical restraints are used in emergency departments (EDs) to address behavioral emergencies in situations in which less restrictive methods have failed. The objective of this study was to evaluate for associations between patient/visit characteristics and physical restraint use. Study Design This study was designed as a cross-sectional, retrospective study of all encounters at Kaiser Permanente Northern California EDs from January 1, 2016, to December 31, 2019, to evaluate differences in patient and visit characteristics between visits involving physical restraint use and those without. Methods Using electronic health record data, this study identified physical restraint use among ED encounters and extracted demographic, clinical, and facility characteristics. The authors calculated odds ratios for physical restraint placement, adjusting for patient and visit characteristics and accounting for within-patient clustering. Results Among 4,410,816 encounters (representing 1,791,673 patients), 6369 encounters (0.1%) involved physical restraint use among 5,554 patients (0.3%). Variables associated with the lowest odds of physical restraint included female sex, presentation to the ED in more recent years, and presence of intentional self-harm/suicidal ideation. Variables associated with the highest odds of physical restraint included higher visit acuity and weekend presentations to the ED. Discussion This study, which leveraged a large, diverse patient sample generalizable to the Northern California population, found several patient and visit characteristics associated with physical restraint use in the ED. Conclusion Results of this study may help identify patient groups and situational factors that are most likely to lead to physical restraint use and structural factors contributing to disparities in care, thereby informing interventions to reduce physical restraint use when possible.

Labor Induction Outcomes with Outpatient Misoprostol for Cervical Ripening among Low-Risk Women.

OBJECTIVE: In 2012, two Kaiser Permanente Northern California (KPNC) hospitals began offering outpatient cervical ripening with oral misoprostol under a study protocol. We evaluated inpatient time from admission to delivery and adverse maternal and neonatal outcomes associated with outpatient use of misoprostol for cervical ripening among low-risk women with term pregnancies. STUDY DESIGN: We conducted a retrospective cohort study comparing three groups: women who received misoprostol (1) outpatient, under a study protocol; (2) inpatient, at the study sites; and (3) inpatient, at all KPNC hospitals. Data were obtained from between 2012 and 2017. The primary outcome was time from inpatient admission to delivery. Secondarily, we evaluated maternal and neonatal outcomes, including the duration and maximum rate of oxytocin administered, rate of cesarean delivery, incidence of chorioamnionitis and blood transfusion, Apgar scores, and neonatal intensive care unit admissions. Demographic and clinical characteristics and outcomes of the outpatient group were compared with both inpatient misoprostol groups using the appropriate statistical test. Variables included in the regression analysis were either statistically significant in the bivariate analyses or have been reported in the literature to be potential confounders: maternal age at admission, race/ethnicity, body mass index, cervical dilation at initial misoprostol, and parity. RESULTS: We analyzed data from 10,253 patients: (1) 345 outpatients, under a study protocol; (2) 1,374 inpatients, at the study sites; and (3) 9,908 inpatients, at all the Kaiser hospitals. Women in the outpatient group were more likely to be white than both inpatient groups (63.3 vs. 56.3% at study sites and 47.1% in all hospitals, p = 0.002 and <0.001, respectively); other demographics were clinically comparable. Most women undergoing labor induction were nulliparous; however, a greater proportion in the outpatient group were nulliparous compared with inpatient groups (70.8 vs. 61.8% and 64.3%, p = 0.002 and 0.01). On inpatient admission for delivery, women who received outpatient misoprostol were more likely to have a cervical dilation of ≥3 cm (39.8 vs. 12.5% at study sites and 9.7% at all KPNC hospitals, p < 0.001 for both). The outpatient group had a shorter mean time between admission and delivery (23.6 vs. 29.4 at study sites and 29.8 hours at all KPNC, p < 0.001 for both). The adjusted estimated mean difference between the outpatient and inpatient group at all the Kaiser hospitals in time from admission to delivery was -6.48 hours (p < 0.001), and the adjusted estimated mean difference in cervical dilation on admission was +1.02 cm (p < 0.001). There was no difference in cesarean delivery rates between groups. The rate of chorioamnionitis in the outpatient group was higher compared with inpatients at all hospitals (17.7 vs. 10.6%, p < 0.001), but similar when compared with the inpatients at the study sites (17.7 vs. 15.4%, p = 0.29). CONCLUSION: Outpatient use of misoprostol for cervical ripening under the study protocol was associated with reduced inpatient time from admission to delivery compared with inpatient misoprostol. Although there was a higher rate of chorioamnionitis among outpatients under the study protocol compared with inpatients at all hospitals, there was no difference when compared with inpatients at the study sites. There was no difference in rates of cesarean delivery or maternal or neonatal complications with outpatient misoprostol. KEY POINTS: · Outpatient misoprostol patients had 6.46 fewer hours from admission to delivery compared with inpatients at all hospitals.. · There was no difference in the rate of cesareans between the outpatient versus inpatient misoprostol groups.. · Other maternal and neonatal complications were low and comparable among outpatients and inpatients who received misoprostol; this study was not large enough to assess rare safety outcomes..

Hepatotoxicity during legacy cancer chemotherapy in patients infected with hepatitis C virus: A retrospective cohort study.

BACKGROUND: The rates and causes of significant hepatotoxicity with cancer chemotherapy (CCT) in patients infected with hepatitis C virus (HCV) are incompletely characterized. METHODS: We compared rates of grade 3 or 4 hepatotoxicity, defined as elevated transaminases, during CCT in patients who are mono-infected with HCV compared with rates in controls matched on demographics, diagnosis, and rituximab use. We excluded patients with hepatobiliary cancers, hepatitis B virus or human immunodeficiency virus infection. Hepatotoxicity was attributed to a medical cause, cancer progression, or CCT, including HCV flare. RESULTS: Patients with HCV (n = 196) had a higher rate of cirrhosis than the 1,130 matched controls (21.9% versus 4%; P <0.001). Their higher rate of overall hepatotoxicity (8.7% versus 4.5% of controls, P = 0.01) was due to higher rate of CCT-related hepatotoxicity (4.1% versus 1.2%, P = 0.01). On multivariable analysis, the largest risk factor for overall hepatotoxicity was cirrhosis, and the only risk factor for CCT-related hepatotoxicity was HCV infection. Among those with HCV, the only significant risk factor for hepatotoxicity was rituximab use. Hepatotoxicity caused by CCT delayed or altered treatment in only 3 HCV patients and 1 control (1.5% versus 0.1%, P = 0.01). CONCLUSIONS: Most patients with HCV can safely be treated with cancer chemotherapy. Cirrhosis and HCV infection contributed to increased hepatotoxicity in subjects on CCT. Among HCV patients, rituximab use was the major risk factor for increased hepatotoxicity. Hepatotoxicity due to CCT itself rarely altered or delayed CCT. Nonetheless, HCV-positive patients should be monitored carefully during CCT.

Iron deficiency and symptoms in women aged 20-49 years and relation to upper gastrointestinal and colon cancers.

OBJECTIVE: Iron deficiency anaemia (IDA) in women aged 20-49 years may be caused by menses or gastrointestinal cancer. Data are sparse on the yield of endoscopy/colonoscopy in this population. Our aim was to determine the association of IDA and symptoms with cancers. DESIGN: Retrospective cohort study within Kaiser Permanente Northern California. Participants were women aged 20-49 years tested for iron stores and anaemia during 1998, 2004 and 2010 and followed for 5 years for outcomes of oesophageal, gastric and colon cancers. Symptoms from the three prior years were grouped into dysphagia, upper gastrointestinal (UGI), lower gastrointestinal (LGI), rectal bleeding and weight loss. RESULTS: Among 9783 anaemic women aged 20-49 years, there were no oesophageal, 6 gastric and 26 colon cancers. Incidences per 1000 for gastric cancer with and without iron deficiency (ID) were 0.60 (95% CI 0.23 to 1.55) and 0.63 (95% CI 0.17 to 2.31), and for colon cancer, 2.72 (95% CI 1.72 to 4.29) and 2.53 (95% CI 1.29 to 4.99). Endoscopies for UGI or dysphagia symptoms rather than bidirectional endoscopy for ID yielded more gastric cancers (n=5 and n=4, respectively) with fewer procedures (3793 instead of 6627). Colonoscopies for LGI or rectal bleed instead of for ID would detect more colon cancers (n=19 and n=18) with about 40% of the procedures (=2793/6627). CONCLUSIONS: UGI and colon cancers were rare in women of menstruating age and when controlled for anaemia were as common without as with ID. Using symptoms rather than IDA as an indication for endoscopy found equal numbers of cancers with fewer procedures.

Surgical Outcomes After Bucket-Handle Meniscal Repairs: Analysis of a Large Contained Cohort.

BACKGROUND: Representing approximately 10% of all meniscal tears, bucket-handle meniscal tears (BHMTs) are large longitudinal vertical tears that have an attached fragment flipped into the intercondylar notch. Meniscectomy often results in significant meniscal loss and increased joint loading. Alternatively, meniscal repair attempts to restore the function of the meniscus and aims to preserve joint mechanics. PURPOSE: To evaluate the long-term risk of subsequent ipsilateral knee surgery in patients who underwent a bucket-handle meniscal repair (BHMR), and to assess risk factors associated with subsequent knee surgical intervention. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: We performed an electronic health record search for all patients aged 12 to 65 years who underwent arthroscopic knee meniscal repairs for BHMT (2011-2018). We excluded patients who had a previous BHMR, did not have magnetic resonance imaging of the knee within 60 days before BHMR, lacked active membership in Kaiser insurance in the year before and after BHMR, or underwent meniscectomy before BHMR. All patients were followed until December 31, 2019, with censoring at death or membership disenrollment. Primary outcomes included ipsilateral knee procedures overall and by type (ie, repeat meniscal repair and meniscectomy); secondary outcomes included other surgical interventions of the same knee, any contralateral knee surgery, deep surgical-site infection, and deep venous thrombosis or pulmonary embolism. RESULTS: The final cohort included 1359 patients with a median age of 24 years (interquartile range [IQR], 17-34) who underwent BHMR for a BHMT. During the follow-up period (median, 50.2 months [IQR, 32.3-60.6]), 495 subsequent ipsilateral procedures were performed in 274 (20.2%) patients, and the median time to the first procedure was 10.6 months (IQR, 4.1-23.5). An overall 59 (4.3%) patients underwent repeat meniscal repair, and 165 (12.1%) had a subsequent meniscectomy of the same knee. Significant risk factors for subsequent ipsilateral procedures included younger age, 12 to 18 years (adjusted odds ratio [aOR], 5.77 [95% CI, 1.84-18.08]) and 19 to 30 years (aOR, 3.65 [95% CI, 1.17-11.36]), as well as normal and overweight body mass index (aOR, 2.84 [95% CI, 1.29-6.23] and 2.34 [95% CI, 1.06-5.17], respectively). Patients undergoing concomitant anterior cruciate ligament reconstruction (ACLR) at the initial BHMR had a lower risk of undergoing subsequent surgery (aOR, 0.66 [95% CI, 0.49-0.87]) than those without concomitant ACLR. CONCLUSION: This is the largest reported study on outcomes after BHMR in a contained cohort. One-fifth of patients underwent subsequent ipsilateral surgery during follow-up, with 4.3% receiving a repeat meniscal repair and 12.1% experiencing a meniscectomy. Risk factors for subsequent surgery of the same knee included younger age and normal or overweight body mass index. Concomitant ACLR at time of BHMR reduced the risk of subsequent reoperation.

Trends in Cannabis Polysubstance Use During Early Pregnancy Among Patients in a Large Health Care System in Northern California.

Importance: Rates of prenatal cannabis use are increasing alongside perceptions that cannabis is a harmless therapeutic for pregnancy-related ailments, while rates of prenatal use of alcohol and tobacco are decreasing. It is important to examine whether cannabis use during pregnancy is increasing similarly among patients with and patients without co-occurring substance use. Objectives: To examine trends in cannabis polysubstance use during pregnancy and to test differences in cannabis use over time among pregnant individuals who use only cannabis vs those who use cannabis and other substances. Design, Setting, and Participants: This cross-sectional time-series study used data from 367 138 pregnancies among 281 590 unique pregnant patients universally screened for prenatal substance use as part of standard care in Kaiser Permanente Northern California from January 1, 2009, to December 31, 2018. Statistical analysis was performed from October 5, 2021, to April 18, 2022. Exposures: Time (calendar year). Main Outcomes and Measures: Use of substances during early pregnancy was assessed via universal screening with a self-administered questionnaire (for cannabis, alcohol, stimulants, and nicotine) and/or positive results of a urine toxicology test (for cannabis, alcohol, stimulants, and pharmaceutical opioids), and data were extracted from the electronic health record. Results: The study sample of 367 138 pregnancies from 281 590 unique pregnant patients (median gestation at time of screening, 8.6 weeks [IQR, 7.3-10.6 weeks]) was 25.9% Asian or Pacific Islander, 6.6% Black, 25.8% Hispanic, 38.0% non-Hispanic White, and 3.6% other race or ethnicity; 1.1% were aged 11 to 17 years, 14.9% were aged 18 to 24 years, 61.9% were aged 25 to 34 years, and 22.1% were aged 35 years or older; and the median neighborhood household income was $70 455 (IQR, $51 563-$92 625). From 2009 to 2018, adjusted rates of use of only cannabis during pregnancy (no other substances) increased substantially from 2.39% (95% CI, 2.20%-2.58%) in 2009 to 6.30% (95% CI, 6.00%-6.60%) in 2018, increasing at an annual relative rate of 1.11 (95% CI, 1.10-1.12). The rate of use of cannabis and 1 other substance also increased (annual relative rate, 1.04 [95% CI, 1.03-1.05]), but not as rapidly (P < .001 for difference), while the rate of use of cannabis and 2 or more other substances decreased slightly (annual relative rate, 0.97 [95% CI, 0.96-0.99]). Adjusted rates of prenatal use of cannabis and alcohol (1.04 [95% CI, 1.03-1.06]) and cannabis and stimulants (1.03 [95% CI, 1.01-1.06]) increased over time, while rates of prenatal use of cannabis and nicotine (0.97 [95% CI, 0.96-0.98]) decreased. Conclusions and Relevance: In this cross-sectional time-series study, rates of prenatal cannabis use during early pregnancy increased significantly more rapidly among patients without co-occurring substance use, which could reflect increased acceptability of cannabis and decreased perceptions of cannabis-related harms. Furthermore, increased rates of use of cannabis with alcohol and stimulants warrant continued monitoring.

Natural History of Asymptomatic Moderate Carotid Artery Stenosis in a Large Community-Based Cohort.

BACKGROUND: Moderate carotid artery stenosis is a poorly defined risk factor for ischemic stroke. As such, practice recommendations are lacking. In this study, we describe the long-term risk of stroke in patients with moderate asymptomatic stenosis in an integrated health care system. METHODS: All adult patients with asymptomatic moderate (50%-69%) internal carotid artery stenosis between 2008 and 2012 were identified, with follow-up through 2017. The primary outcome was acute ischemic stroke attributed to the ipsilateral carotid artery. Stroke rates were calculated using competing risk analysis. Secondary outcomes included disease progression, ipsilateral intervention, and long-term survival. RESULTS: Overall, 11 614 arteries with moderate stenosis in 9803 patients were identified. Mean age was 74.2±9.9 years with 51.4% women. Mean follow-up was 5.1±2.9 years. There were 180 ipsilateral ischemic strokes (1.6%) identified (crude annual risk, 0.31% [95% CI, 0.21%-0.41%]), of which thirty-one (17.2%) underwent subsequent intervention. Controlling for death and intervention as competing risks, the cumulative incidence of stroke was 1.2% (95% CI, 1.0%-1.4%) at 5 years and 2.0% (95% CI, 1.7%-2.4%) at 10 years. Of identified strokes, 50 (27.8%) arteries had progressed to severe stenosis or occlusion. During follow-up, there were 17 029 carotid studies performed in 5951 patients, revealing stenosis progression in 1674 (14.4%) arteries, including 1614 (13.9%) progressing to severe stenosis and 60 (0.5%) to occlusion. The mean time to stenosis progression was 2.6±2.1 years. Carotid intervention occurred in 708 arteries (6.1%). Of these, 66.1% (468/708) had progressed to severe stenosis. The overall mortality rate was 44.5%, with 10.5% of patients lost to follow-up. CONCLUSIONS: In this community-based sample of patients with asymptomatic moderate internal carotid artery stenosis followed for an average of 5 years, the cumulative incidence of stroke is low out to 10 years. Future research is needed to optimize management strategies for this population.

Incidence of Ischemic Stroke in Patients With Asymptomatic Severe Carotid Stenosis Without Surgical Intervention.

Importance: Optimal management of patients with asymptomatic severe carotid stenosis is uncertain, due to advances in medical care and a lack of contemporary data comparing medical and surgical treatment. Objective: To estimate stroke outcomes among patients with medically treated asymptomatic severe carotid stenosis who did not undergo surgical intervention. Design, Setting, and Participants: Retrospective cohort study that included 3737 adult participants with asymptomatic severe (70%-99%) carotid stenosis diagnosed between 2008 and 2012 and no prior intervention or ipsilateral neurologic event in the prior 6 months. Participants received follow-up through 2019, and all were members of an integrated US regional health system serving 4.5 million members. Exposures: Imaging diagnosis of asymptomatic carotid stenosis of 70% to 99%. Main Outcomes and Measures: Occurrence of ipsilateral carotid-related acute ischemic stroke. Censoring occurred with death, disenrollment, or ipsilateral intervention. Results: Among 94 822 patients with qualifying imaging studies, 4230 arteries in 3737 (mean age, 73.8 [SD 9.5 years]; 57.4% male) patients met selection criteria including 2539 arteries in 2314 patients who never received intervention. The mean follow-up in this cohort was 4.1 years (SD 3.6 years). Prior to any intervention, there were 133 ipsilateral strokes with a mean annual stroke rate of 0.9% (95% confidence interval [CI], 0.7%-1.2%). The Kaplan-Meier estimate of ipsilateral stroke by 5 years was 4.7% (95% CI, 3.9%-5.7%). Conclusions and Relevance: In a community-based cohort of patients with asymptomatic severe carotid stenosis who did not undergo surgical intervention, the estimated rate of ipsilateral carotid-related acute ischemic stroke was 4.7% over 5 years. These findings may inform decision-making regarding surgical and medical treatment for patients with asymptomatic severe carotid artery stenosis.

Minimally invasive myomectomy: practice trends and differences between Black and non-Black women within a large integrated healthcare system.

BACKGROUND: Although multiple professional organizations encourage minimally invasive surgical approaches whenever feasible, nationally, fewer than half of myomectomies are performed via minimally invasive routes. Black women are less likely than their non-Black counterparts to have minimally invasive surgery. OBJECTIVE: This study aimed to assess the trends in surgical approach among women who underwent minimally invasive myomectomies for uterine leiomyomas within a large integrated healthcare system as initiatives were implemented to encourage minimally invasive surgery, particularly evaluating differences in the proportion of minimally invasive surgery performed in Black vs non-Black women. STUDY DESIGN: We conducted a retrospective cohort study of women, aged ≥18 years, who underwent a myomectomy for a uterine leiomyoma within Kaiser Permanente Northern California between 2009 and 2019. Generalized estimating equations and Cochran-Armitage testing were used to assess myomectomy incidence and linear trend in the proportions of myomectomy by surgical route-abdominal myomectomy and minimally invasive myomectomy. Multivariable logistic regression analyses were used to assess the associations between surgical route and (1) race and ethnicity and (2) complications, controlling for patient demographic, clinical, and surgical characteristics. RESULTS: A total of 4033 adult women underwent a myomectomy during the study period. Myomectomy incidence doubled from 0.12 (95% confidence interval, 0.12-0.13) per 1000 women in 2009 to 0.25 (95% confidence interval, 0.24-0.25) per 1000 women in 2019 (P<.001). During the 11-year study period, the proportion of minimally invasive myomectomy increased from 6.0% to 89.5% (a 15-fold increase). The proportion of minimally invasive myomectomy in Black women remained lower than in non-Black women (54.5% vs 64.7%; P<.001). Black women undergoing myomectomy were younger (36.4±5.6 vs 37.4±5.8 years; P<.001), had a higher mean fibroid weight (436.0±505.0 vs 324.7±346.1 g; P<.001), and had a higher mean body mass index (30.8±7.3 vs 26.6±5.9 kg/m2; P<.001) than their non-Black counterparts. In addition to patient race, surgery performed between 2016 and 2019 compared with surgery performed between 2009 and 2012 and higher surgeon volume compared with low surgeon volume were associated with an increased proportion of minimally invasive myomectomy (adjusted relative risks, 12.58 [95% confidence interval, 9.96-15.90] and 6.63 [95% confidence interval, 5.35-8.21], respectively). Black race and fibroid weight of >500 g each independently conferred lower rates of minimally invasive myomectomy. In addition, there was an interaction between race and fibroid weight such that Black women with a fibroid weight of ≤500 g or >500 g were both less likely to have minimally invasive myomectomy than non-Black women with a fibroid weight of ≤500 g (adjusted relative risks, 0.74 [95% confidence interval, 0.58-0.95] and 0.26 [95% confidence interval, 0.18-0.36], respectively). Operative, perioperative, and medical complications were low during the 11-year study period. In regression analyses, after controlling for race, age, fibroid weight, parity, low-income residence, body mass index, surgeon volume, and year of myomectomy, the risk of complications was not markedly different comparing abdominal myomectomy with minimally invasive myomectomy. Similar results were found comparing laparoscopic minimally invasive myomectomy with robotic-assisted minimally invasive myomectomy except for women who underwent laparoscopic minimally invasive myomectomy had a lower risk of experiencing any medical complications than those who underwent robotic-assisted minimally invasive myomectomy (adjusted relative risk, 0.27; 95% confidence interval, 0.09-0.83; P=.02). CONCLUSION: Within an integrated healthcare delivery system, although initiatives to encourage minimally invasive surgery were associated with a marked increase in the proportion of minimally invasive myomectomy, Black women continued to be less likely to undergo minimally invasive myomectomy than their non-Black counterparts. Race and fibroid weight alone did not explain the disparities in minimally invasive myomectomy.

Comparison of Anterior Cruciate Ligament Tears Treated Nonoperatively Versus With Reconstruction: Risk of Subsequent Surgery.

BACKGROUND: Anterior cruciate ligament (ACL) tears can be devastating injuries, leading to joint instability, meniscal tears, and subsequent arthritis. It is unknown whether ACL reconstruction (ACLR) alters the natural history of joint degeneration in the ACL-deficient knee compared with nonoperative treatment, and few studies have examined outcomes in middle-aged patients. PURPOSE: The objective of this study was to compare the midterm risk of subsequent ipsilateral knee surgery in middle-aged patients after an ACL injury treated with initial conservative (nonoperative) management (CM) versus ACLR (operative management [OM]) within 6 months of the diagnosis. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: We performed an electronic database search from 2011 to 2012 for all patients aged 35 to 55 years with an initial diagnosis of magnetic resonance imaging-confirmed ACL tear. Patients who elected CM and those who underwent ACLR within 6 months of the diagnosis (OM) were identified. Index patient and clinical characteristics were collected from the health record. All patients were longitudinally observed until August 31, 2017. The primary outcome was subsequent ipsilateral knee surgeries, and secondary outcomes included contralateral knee surgeries, deep surgical-site infections, and venous thrombotic events. RESULTS: The mean follow-up was 4.8 ± 0.6 years. The CM group included 463 patients (40.2%) and the OM group included 690 patients (59.8%). The mean ages were 43.9 ± 5.7 years and 42.7 ± 5.3 years for patients in the CM and OM groups, respectively (P < .001). Obesity and smoking were significantly more common in the CM group. During the follow-up, 180 patients (38.9%) in the CM group underwent subsequent ipsilateral knee surgery compared with 73 (10.6%) patients in the OM group (P < .001). The mean time to the first ipsilateral procedure was 0.9 ± 1.1 years in the CM and 2 ± 1.5 years in the OM group (P < .001). Delayed ipsilateral ACLRs were performed in 81 patients in the CM group (17.5%); non-ACLR ipsilateral knee surgeries were performed in 156 patients in the CM group (33.7%). Contralateral knee surgery rates were similar. In a regression model, after controlling for age, sex, the Charlson Comorbidity Index score, and smoking status, it was found that normal body mass index and CM group were risk factors for undergoing subsequent knee surgery or ipsilateral non-ACLR surgery. CONCLUSION: Excluding delayed ACLR, subsequent ipsilateral knee surgeries were more common and occurred earlier in middle-aged patients with nonoperatively managed ACL tears compared with patients managed with reconstruction.

Association of Pregnancy Intentions With Substance Use During Early Pregnancy.

OBJECTIVES: The goal of this study was to evaluate the association between pregnancy intentions and substance use in early pregnancy among pregnant women receiving prenatal care in a large, integrated healthcare system. METHODS: The sample comprised 29,787 Kaiser Permanente Northern California pregnant women (12.1% aged <25, 36.4% non-Hispanic White) screened for prenatal substance use in 2018 via a self-reported questionnaire and urine toxicology test given as part of standard prenatal care (at ∼8 weeks gestation). Multivariable logistic regression models tested for associations of pregnancy intentions with prenatal substance use (any use and specific substances) by self-report and/or a positive urine toxicology test. RESULTS: Adjusting for covariates, women with an unintended pregnancy (23.9% of the sample) had higher odds of any prenatal substance use than women with an intended pregnancy (28.8% vs 16.1%; adjusted odds ratio [aOR] = 1.80, 95% confidence interval [CI]:1.67-1.93). Having an unintended pregnancy was also associated with higher odds of using alcohol (14.4% vs 10.4%; aOR = 1.73, 95%CI:1.59-1.89), cannabis (15.6% vs 5.6%; aOR = 1.91, 95%CI:1.73-2.11), nicotine (3.8% vs 1.3%; aOR = 2.33, 95%CI:1.92-2.82), pain medication (2.3% vs 1.2%; aOR = 1.64, 95%CI:1.32-2.03), and stimulants (0.8% vs 0.3%; aOR = 1.85, 95%CI:1.23-2.79) early in pregnancy. DISCUSSION: Having an unintended pregnancy was associated with higher odds of substance use during early pregnancy. Connecting women of reproductive age with health education about pregnancy prevention and recognition of early signs of pregnancy, effective contraception, and early screening and interventions for prenatal substance use may help to reduce prenatal substance use and its associated consequences.

Improving Caregiver Health through Systematic Assessment and a Tailored Plan of Care.

Caregivers often experience strain and negative effects on their well-being. We tested the effects of a caregiver assessment and tailored care plan for caregivers of patients transitioning home from an inpatient rehabilitation facility (IRF), a study involving two groups: usual care (n = 225) (preimplementation) and intervention (postimplementation) (n = 215). Caregivers in the intervention group were assessed using the 25-item self-reported Preparedness Assessment for the Transition Home during the IRF stay. A tailored care plan was implemented in response to the assessment. Caregivers in both groups completed the Modified Caregiver Strain Index and Global Health Scale at 30- and 90-day postdischarge. After adjusting for baseline and demographics, caregivers in the intervention group reported lower strain (p < .01) and better overall health (p < .05) at 30-day post-IRF discharge, relative to usual care. Implementing a systematic caregiver assessment and tailored care plan in the IRF may mitigate the adverse effects of caregiving.

Active versus Passive Voiding Protocols after Same-day Minimally Invasive Hysterectomy.

STUDY OBJECTIVE: To determine the proportion of patients discharged with a urinary catheter after a same-day benign gynecologic minimally invasive hysterectomy (MIH) according to active vs passive voiding protocols. The secondary objectives included assessing postanesthesia care unit (PACU) duration and postoperative urinary retention (POUR) rate ≤2 weeks of discharge. DESIGN: Retrospective, observational cohort study. SETTING: Large integrated healthcare system serving approximately 40% of the Northern California population. PATIENTS: Patients aged 18 years or older undergoing same-day MIH without urogynecology procedures from 2015 to 2018 were categorized into active or passive voiding trial groups. Active voiding trials were defined as patients arriving in the PACU with a catheter, retrograde filling of the bladder with 300 mL saline then allowing for voiding ≥50% within 30 minutes. If the patients were unable to void this volume, they were discharged with a catheter to be removed within 24 hours. A passive voiding trial involved filling or not filling the bladder before PACU arrival without a catheter, then allowing for voiding or performing a straight catheterization if the patients were unable to void. INTERVENTIONS: Retrospective cohort study. MEASUREMENTS AND MAIN RESULTS: A total of 1644 (83.2%) patients underwent passive voiding trials, and 333 (16.8%) underwent active voiding trials. The proportion of patients discharged with a catheter was lower in the passive voiding group than in the active voiding group (5.4% vs 10.5%; p = .001). The passive group had a shorter mean PACU time than the active group (218 ± 86 vs 240 ± 93 minutes; p <.001). The crude POUR rates for the passive and active voiding groups were 1.8% and 3.0%, respectively (p = .16). CONCLUSION: Within an integrated healthcare system, patients who underwent passive voiding trials compared with those who underwent active voiding trials were discharged home from the PACU after a shorter duration. In addition, a larger proportion of the patients who underwent passive voiding trials were discharged home without a urinary catheter. There were no differences in the POUR rates. Our findings suggest that passive voiding trials can be safely used after a benign MIH to reduce hospital duration, optimize healthcare resources, and improve patient experience.

Variation in Vaginal Hysterectomy Rates in an Integrated Healthcare System.

STUDY OBJECTIVE: To describe trends in minimally invasive hysterectomy (MIH) and assess patient, surgical, and provider characteristics associated with differences in vaginal versus laparoscopic rates within an integrated healthcare system. DESIGN: A retrospective cohort study. SETTING: Kaiser Permanente Northern California from 2008 to 2018. PATIENTS: Patients who underwent MIH for benign conditions excluding uterine prolapse and incontinence surgeries. INTERVENTIONS: Hysterectomies. MEASUREMENTS AND MAIN RESULTS: A total of 27518 hysterectomies were performed for benign indications. Of these, the proportion of MIH increased from 29.1% (2008) to 96.7% (2018) (p <.001). The proportion of vaginal hysterectomies (VHs) of all hysterectomies did not change significantly over the study period (p = .07); however, the proportion of VH among MIH cases decreased from a high of 50.6% in 2008 to 13.2% in 2018 (p <.001). VH rates were lower in obese and morbidly obese patients (p <.001 and p = .02, respectively) and in women with uterine weights >250 g (p <.001). The differences persisted after controlling for patient demographic, clinical, and surgery characteristics. Low surgical volume was inversely associated with VH (adjusted relative risk, 7.19; 95% confidence interval, 6.62-7.81; p <.001). VH rates ranged from 11.5% to 27.8% across service areas (hospitals). Service area remained a significant predictor of VH after controlling for patient (including body mass index and uterine weight) and surgery-related characteristics. Postoperative hospital stay decreased from 33.8 ± 16.4 hours (2008) to 6.1 ± 12.2 (2018) for VH. Operative time was shorter for VH than laparoscopic hysterectomies (LHs) (1.7 vs 2.5 hours; p <.001). Overall operative/perioperative complications were low and not significantly different (VH vs LH). CONCLUSION: As the proportion of MIH increased, LH became the preferred route despite similar rates of postoperative stay and intraoperative complications and shorter operative time for VH compared with LH. Service area and provider volume were independent predictors of MIH route, suggesting that training and evidence-based guidelines for route selection may help preserve VH rates.